Data from clinical trials of drotrecogin alfa (activated) (Xigris) suggest that all-cause mortality was numerically higher in patients with single organ dysfunction and recent surgery who were taking drotrecogin alfa compared with patients taking a placebo.
Based on these findings, the warning section of the labeling of drotrecogin alfa now states that patients with single organ dysfunction and recent surgery may not be in the group of patients indicated for treatment with drotrecogin alfa.
Drotrecogin alfa is indicated for the treatment of adult patients with severe sepsis who are at high risk of death. According to the manufacturer, Eli Lili, patients with single organ dysfunction and recent surgery may not be at high risk of death irrespective of APACHE II score, and therefore may not be among the indicated population. Drotrecogin alfa should be used in such patients only after careful consideration of the risks and benefits.